Psoriasis

Phototherapy remains a viable element of psoriasis care for many patients, used alone or in conjunction with other treatments, according to updated guidelines issued jointly by the American Academy of Dermatology and the National Psoriasis Foundation.

“Phototherapy serves as a reasonable and effective treatment option for patients requiring more than topical medications and/or those wishing to avoid systemic medications or simply seeking an adjunct to a failing regimen,” wrote working group cochair Craig A. Elmets, MD, professor of dermatology at the University of Alabama at Birmingham, and coauthors.

The guidelines, which focus on phototherapy for adults with psoriasis, join a multipart series on psoriasis being published this year in the Journal of the American Academy of Dermatology.

The working group used an evidence-based model to examine efficacy, effectiveness, and adverse effects of the following modalities: narrow-band ultraviolet B (NB-UVB); broadband ultraviolet B (BB-UVB); targeted phototherapy using excimer laser and excimer lamp; psoralen plus ultraviolet A (PUVA) therapy, including topical, oral, and bath PUVA; photodynamic therapy (PDT), grenz ray therapy, climatotherapy; visible light therapy; Goeckerman therapy; and pulsed dye laser/intense pulsed light.

NB-UVB, which can be used to treat generalized plaque psoriasis, refers to wavelengths of 311-313 nm. The recommended treatment is two or three times a week, with a starting dose based on skin phenotype or minimal erythema dose. Although oral PUVA has shown higher clearance rates, compared with NB-UVB, NB-UVB has demonstrated fewer side effects. NB-UVB also has shown effectiveness for psoriasis in combination with medications including oral retinoids, “particularly useful in patients at increased risk for skin cancer,” the working group wrote. Genital shielding and eye protection are recommended during all phototherapy sessions to reduce the risk of cancer and cataracts, they emphasized.

BB-UVB, an older version of NB-UVB, is still effective for generalized plaque psoriasis as monotherapy, but evidence does not support additional benefit in combination with other treatments, and overall BB-UVB is less effective than either NB-UVB or oral PUVA, the working group said.

For treatment of localized psoriatic lesions, some evidence supports the ability of targeted UVB therapy to improve lesions in fewer treatments and at a lower cumulative dose, compared with nontargeted phototherapy, for palmoplantar plaque psoriasis and palmoplantar pustulosis. Excimer lasers also have shown effectiveness against scalp psoriasis, the working group noted. However, “there is insufficient evidence to recommend the excimer laser rather than topical PUVA for treatment of localized plaque psoriasis,” they said.

PUVA treatments are available as topical creams, or they can be taken orally, or mixed with bath water. All forms of PUVA include psoralens, photosensitizing agents that prepare target cells for the effects of UVA light. Topical PUVA has demonstrated particular effectiveness for palmoplantar psoriasis, the working group noted, but there is a risk of phototoxicity, so it has become less popular, they added. Similarly, evidence supports effectiveness of oral and bath PUVA, but all forms are used less frequently because of the increased availability of NB-UVB phototherapy, they said.

PDT is primarily used to destroy premalignant or malignant cells, and in theory “PDT-induced apoptosis of T lymphocytes could lead to reductions in inflammatory cytokines and, in turn, to improvement of psoriasis,” the working group noted. However, “clinical studies have failed to find significant benefit” of PDT using either 5-aminolevulinic acid (ALA) or methyl aminolevulinic acid (MAL) for psoriasis, or any significant benefits of MAL-PDT for nail psoriasis.

The grenz ray is an effective, but rarely used treatment in which 75% of long-wavelength ionizing radiation is absorbed by the first 1 mm of skin and 95% is absorbed within the first 3 mm of skin to protect the deeper tissues from radiation. Although more alternatives are available, grenz rays can be used for psoriasis patients unable to tolerate UV therapy, according to the working group.

Climatotherapy involves temporary or permanent relocation of the patient to a part of the world with a climate that could be favorable for psoriasis because of the unique effects of environmental factors in those areas. The evidence to support climatotherapy is both subjective and objective, but considered safe.

Visible light has been associated with improvement in erythema in psoriasis, with hyperpigmentation as the only notable side effect based on the evidence reviewed. However, the working group found the current evidence insufficient to recommend the use of intense pulsed light for treating psoriasis.

Goeckerman therapy, a method that combines coal tar and UVB phototherapy, has shown safety and effectiveness for patients with recalcitrant or severe psoriasis, and remains a recommended treatment, according to the working group research. However, this method is underused, especially in the United States, because of the messiness of the application, challenge of insurance reimbursement, and investment of time for outpatient care, the work group noted.

Pulsed dye laser treatment is effective for nail psoriasis, and reported adverse effects have been mild, according to the working group.

Overall, the guidelines emphasize that quality of life and disease severity should be considered and discussed with patients along with efficacy and safety information so they can make informed decisions about adding phototherapy to a current regimen or switching among modalities.

The guidelines have no funding sources. Several coauthors disclosed relationships with multiple companies, including manufacturers of psoriasis products; however, a minimum of 51% of the work group had no relevant financial conflicts to disclose, in accordance with AAD policy. Work group members with potential conflicts recused themselves from discussion and drafting of recommendations in the relevant topic areas. Alan Menter, MD, chairman of the division of dermatology, Baylor University Medical Center, Dallas, is the other cochair of the work group.
 

SOURCE: Elmets CA et al. J Am Acad Dermatol. 2019 Jul 18. doi: 10.1016/j.jaad.2019.04.042.

Phototherapy remains a viable element of psoriasis care for many patients, used alone or in conjunction with other treatments, according to updated guidelines issued jointly by the American Academy of Dermatology and the National Psoriasis Foundation.

“Phototherapy serves as a reasonable and effective treatment option for patients requiring more than topical medications and/or those wishing to avoid systemic medications or simply seeking an adjunct to a failing regimen,” wrote working group cochair Craig A. Elmets, MD, professor of dermatology at the University of Alabama at Birmingham, and coauthors.

The guidelines, which focus on phototherapy for adults with psoriasis, join a multipart series on psoriasis being published this year in the Journal of the American Academy of Dermatology.

The working group used an evidence-based model to examine efficacy, effectiveness, and adverse effects of the following modalities: narrow-band ultraviolet B (NB-UVB); broadband ultraviolet B (BB-UVB); targeted phototherapy using excimer laser and excimer lamp; psoralen plus ultraviolet A (PUVA) therapy, including topical, oral, and bath PUVA; photodynamic therapy (PDT), grenz ray therapy, climatotherapy; visible light therapy; Goeckerman therapy; and pulsed dye laser/intense pulsed light.

NB-UVB, which can be used to treat generalized plaque psoriasis, refers to wavelengths of 311-313 nm. The recommended treatment is two or three times a week, with a starting dose based on skin phenotype or minimal erythema dose. Although oral PUVA has shown higher clearance rates, compared with NB-UVB, NB-UVB has demonstrated fewer side effects. NB-UVB also has shown effectiveness for psoriasis in combination with medications including oral retinoids, “particularly useful in patients at increased risk for skin cancer,” the working group wrote. Genital shielding and eye protection are recommended during all phototherapy sessions to reduce the risk of cancer and cataracts, they emphasized.

BB-UVB, an older version of NB-UVB, is still effective for generalized plaque psoriasis as monotherapy, but evidence does not support additional benefit in combination with other treatments, and overall BB-UVB is less effective than either NB-UVB or oral PUVA, the working group said.

For treatment of localized psoriatic lesions, some evidence supports the ability of targeted UVB therapy to improve lesions in fewer treatments and at a lower cumulative dose, compared with nontargeted phototherapy, for palmoplantar plaque psoriasis and palmoplantar pustulosis. Excimer lasers also have shown effectiveness against scalp psoriasis, the working group noted. However, “there is insufficient evidence to recommend the excimer laser rather than topical PUVA for treatment of localized plaque psoriasis,” they said.

PUVA treatments are available as topical creams, or they can be taken orally, or mixed with bath water. All forms of PUVA include psoralens, photosensitizing agents that prepare target cells for the effects of UVA light. Topical PUVA has demonstrated particular effectiveness for palmoplantar psoriasis, the working group noted, but there is a risk of phototoxicity, so it has become less popular, they added. Similarly, evidence supports effectiveness of oral and bath PUVA, but all forms are used less frequently because of the increased availability of NB-UVB phototherapy, they said.

PDT is primarily used to destroy premalignant or malignant cells, and in theory “PDT-induced apoptosis of T lymphocytes could lead to reductions in inflammatory cytokines and, in turn, to improvement of psoriasis,” the working group noted. However, “clinical studies have failed to find significant benefit” of PDT using either 5-aminolevulinic acid (ALA) or methyl aminolevulinic acid (MAL) for psoriasis, or any significant benefits of MAL-PDT for nail psoriasis.

The grenz ray is an effective, but rarely used treatment in which 75% of long-wavelength ionizing radiation is absorbed by the first 1 mm of skin and 95% is absorbed within the first 3 mm of skin to protect the deeper tissues from radiation. Although more alternatives are available, grenz rays can be used for psoriasis patients unable to tolerate UV therapy, according to the working group.

Climatotherapy involves temporary or permanent relocation of the patient to a part of the world with a climate that could be favorable for psoriasis because of the unique effects of environmental factors in those areas. The evidence to support climatotherapy is both subjective and objective, but considered safe.

Visible light has been associated with improvement in erythema in psoriasis, with hyperpigmentation as the only notable side effect based on the evidence reviewed. However, the working group found the current evidence insufficient to recommend the use of intense pulsed light for treating psoriasis.

Goeckerman therapy, a method that combines coal tar and UVB phototherapy, has shown safety and effectiveness for patients with recalcitrant or severe psoriasis, and remains a recommended treatment, according to the working group research. However, this method is underused, especially in the United States, because of the messiness of the application, challenge of insurance reimbursement, and investment of time for outpatient care, the work group noted.

Pulsed dye laser treatment is effective for nail psoriasis, and reported adverse effects have been mild, according to the working group.

Overall, the guidelines emphasize that quality of life and disease severity should be considered and discussed with patients along with efficacy and safety information so they can make informed decisions about adding phototherapy to a current regimen or switching among modalities.

The guidelines have no funding sources. Several coauthors disclosed relationships with multiple companies, including manufacturers of psoriasis products; however, a minimum of 51% of the work group had no relevant financial conflicts to disclose, in accordance with AAD policy. Work group members with potential conflicts recused themselves from discussion and drafting of recommendations in the relevant topic areas. Alan Menter, MD, chairman of the division of dermatology, Baylor University Medical Center, Dallas, is the other cochair of the work group.
 

SOURCE: Elmets CA et al. J Am Acad Dermatol. 2019 Jul 18. doi: 10.1016/j.jaad.2019.04.042.

Phototherapy remains a viable element of psoriasis care for many patients, used alone or in conjunction with other treatments, according to updated guidelines issued jointly by the American Academy of Dermatology and the National Psoriasis Foundation.

“Phototherapy serves as a reasonable and effective treatment option for patients requiring more than topical medications and/or those wishing to avoid systemic medications or simply seeking an adjunct to a failing regimen,” wrote working group cochair Craig A. Elmets, MD, professor of dermatology at the University of Alabama at Birmingham, and coauthors.

The guidelines, which focus on phototherapy for adults with psoriasis, join a multipart series on psoriasis being published this year in the Journal of the American Academy of Dermatology.

The working group used an evidence-based model to examine efficacy, effectiveness, and adverse effects of the following modalities: narrow-band ultraviolet B (NB-UVB); broadband ultraviolet B (BB-UVB); targeted phototherapy using excimer laser and excimer lamp; psoralen plus ultraviolet A (PUVA) therapy, including topical, oral, and bath PUVA; photodynamic therapy (PDT), grenz ray therapy, climatotherapy; visible light therapy; Goeckerman therapy; and pulsed dye laser/intense pulsed light.

NB-UVB, which can be used to treat generalized plaque psoriasis, refers to wavelengths of 311-313 nm. The recommended treatment is two or three times a week, with a starting dose based on skin phenotype or minimal erythema dose. Although oral PUVA has shown higher clearance rates, compared with NB-UVB, NB-UVB has demonstrated fewer side effects. NB-UVB also has shown effectiveness for psoriasis in combination with medications including oral retinoids, “particularly useful in patients at increased risk for skin cancer,” the working group wrote. Genital shielding and eye protection are recommended during all phototherapy sessions to reduce the risk of cancer and cataracts, they emphasized.

BB-UVB, an older version of NB-UVB, is still effective for generalized plaque psoriasis as monotherapy, but evidence does not support additional benefit in combination with other treatments, and overall BB-UVB is less effective than either NB-UVB or oral PUVA, the working group said.

For treatment of localized psoriatic lesions, some evidence supports the ability of targeted UVB therapy to improve lesions in fewer treatments and at a lower cumulative dose, compared with nontargeted phototherapy, for palmoplantar plaque psoriasis and palmoplantar pustulosis. Excimer lasers also have shown effectiveness against scalp psoriasis, the working group noted. However, “there is insufficient evidence to recommend the excimer laser rather than topical PUVA for treatment of localized plaque psoriasis,” they said.

PUVA treatments are available as topical creams, or they can be taken orally, or mixed with bath water. All forms of PUVA include psoralens, photosensitizing agents that prepare target cells for the effects of UVA light. Topical PUVA has demonstrated particular effectiveness for palmoplantar psoriasis, the working group noted, but there is a risk of phototoxicity, so it has become less popular, they added. Similarly, evidence supports effectiveness of oral and bath PUVA, but all forms are used less frequently because of the increased availability of NB-UVB phototherapy, they said.

PDT is primarily used to destroy premalignant or malignant cells, and in theory “PDT-induced apoptosis of T lymphocytes could lead to reductions in inflammatory cytokines and, in turn, to improvement of psoriasis,” the working group noted. However, “clinical studies have failed to find significant benefit” of PDT using either 5-aminolevulinic acid (ALA) or methyl aminolevulinic acid (MAL) for psoriasis, or any significant benefits of MAL-PDT for nail psoriasis.

The grenz ray is an effective, but rarely used treatment in which 75% of long-wavelength ionizing radiation is absorbed by the first 1 mm of skin and 95% is absorbed within the first 3 mm of skin to protect the deeper tissues from radiation. Although more alternatives are available, grenz rays can be used for psoriasis patients unable to tolerate UV therapy, according to the working group.

Climatotherapy involves temporary or permanent relocation of the patient to a part of the world with a climate that could be favorable for psoriasis because of the unique effects of environmental factors in those areas. The evidence to support climatotherapy is both subjective and objective, but considered safe.

Visible light has been associated with improvement in erythema in psoriasis, with hyperpigmentation as the only notable side effect based on the evidence reviewed. However, the working group found the current evidence insufficient to recommend the use of intense pulsed light for treating psoriasis.

Goeckerman therapy, a method that combines coal tar and UVB phototherapy, has shown safety and effectiveness for patients with recalcitrant or severe psoriasis, and remains a recommended treatment, according to the working group research. However, this method is underused, especially in the United States, because of the messiness of the application, challenge of insurance reimbursement, and investment of time for outpatient care, the work group noted.

Pulsed dye laser treatment is effective for nail psoriasis, and reported adverse effects have been mild, according to the working group.

Overall, the guidelines emphasize that quality of life and disease severity should be considered and discussed with patients along with efficacy and safety information so they can make informed decisions about adding phototherapy to a current regimen or switching among modalities.

The guidelines have no funding sources. Several coauthors disclosed relationships with multiple companies, including manufacturers of psoriasis products; however, a minimum of 51% of the work group had no relevant financial conflicts to disclose, in accordance with AAD policy. Work group members with potential conflicts recused themselves from discussion and drafting of recommendations in the relevant topic areas. Alan Menter, MD, chairman of the division of dermatology, Baylor University Medical Center, Dallas, is the other cochair of the work group.
 

SOURCE: Elmets CA et al. J Am Acad Dermatol. 2019 Jul 18. doi: 10.1016/j.jaad.2019.04.042.

AUSTIN, TEX. – Among children with psoriasis, there appears to be no strong evidence that biologic immunomodulating drugs increase the 6-month risk of serious infections, compared with systemic nonbiologics or phototherapy, according to results from the largest population-based study of its kind to date.

However, children with psoriasis face a 64% increased risk of infection, compared with risk-matched pediatric patients without the disease.

“We know that pediatric psoriasis affects up to 1.3% of children, and we know that is associated with multiple potential comorbidities and that it has a significant impact on quality of life for children affected,” lead study author Maria Schneeweiss, MD, said at the annual meeting of the Society for Pediatric Dermatology. “Increasingly, we see that biologic and nonbiologic systemic agents are used to treat moderate to severe pediatric psoriasis. While we have a lot of experience in adult psoriasis and a lot of comparative safety studies of these drugs in adult psoriasis, there are very few population-based studies on the safety of these systemic agents for treating pediatric psoriasis.”

In an effort to evaluate the 6-month risk of serious bacterial and opportunistic infections in children with psoriasis treated with systemic immunomodulatory medications, Dr. Schneeweiss and Joseph F. Merola, MD, of the department of dermatology at Brigham and Women’s Hospital, Boston, and Jennifer Huang, MD, of Boston Children’s Hospital drew from longitudinal, patient-level U.S. claims data in the MarketScan database between 2003 and 2017. They limited the analysis to patients younger than age 18; those who had a recorded diagnosis of psoriasis; and those who were treated with biologics, nonbiologic immunomodulatory agents, or phototherapy. The researchers used hospital discharge diagnoses to compute the risk of serious bacterial and opportunistic infections, and propensity score matching to determine relative risks.

A total of 54,355 children with psoriasis were identified in the database. Before propensity score matching, 635 patients initiated biologic therapy, 919 initiated nonbiologic systemic agents, and 2,537 initiated phototherapy. Their mean age was 12-14 years and slightly more than half were female. In nonbiologic initiators, the 6-month risk of serious infections was 4.75 per 1,000 patients, while in biologic initiators it was 5.44 per 1,000 patients, resulting in a propensity score–matched ratio of 0.60. There was no statistically significant increased risk when the use of nonbiologics was compared with the use of phototherapy.

Independent of treatment, the risk of infection among psoriasis patients was 1.1 per 1,000 patients, which was 60% higher than matched pediatric patients without psoriasis (risk ratio, 1.64).

“When treating pediatric patients with psoriasis, clinicians should remain mindful that the presence of psoriasis itself may increase the risk of infection in children and adolescents, independent of treatment, but that biologic immunomodulatory agents do not further increase that risk,” Dr. Schneeweiss said in an interview. “Our findings suggest that, while there may be an increased risk of certain infections based on the presence of psoriasis alone, all appropriate treatment options should be discussed with patients in shared decision making with their physician. Patients should understand the risks, benefits, and alternatives to any treatment option but not necessarily be restricted as such and have access to newer, targeted and highly effective therapy as appropriate to each individual case.”

She added that, based on the National Psoriasis Foundation guidance of treat-to-target strategies, “our pediatric patients should be offered the same level of disease control as all psoriasis patients.”

She acknowledged certain limitations of the analysis, including the inability to stratify by disease severity and to determine specific doses of medication used.

The study was funded by the Brigham and Women’s Hospital departments of dermatology and medicine. Dr. Schneeweiss and Dr. Huang reported having no financial disclosures. Dr. Merola reported that he has served as a consultant and/or investigator for numerous pharmaceutical companies.

dbrunk@mdedge.com

AUSTIN, TEX. – Among children with psoriasis, there appears to be no strong evidence that biologic immunomodulating drugs increase the 6-month risk of serious infections, compared with systemic nonbiologics or phototherapy, according to results from the largest population-based study of its kind to date.

However, children with psoriasis face a 64% increased risk of infection, compared with risk-matched pediatric patients without the disease.

“We know that pediatric psoriasis affects up to 1.3% of children, and we know that is associated with multiple potential comorbidities and that it has a significant impact on quality of life for children affected,” lead study author Maria Schneeweiss, MD, said at the annual meeting of the Society for Pediatric Dermatology. “Increasingly, we see that biologic and nonbiologic systemic agents are used to treat moderate to severe pediatric psoriasis. While we have a lot of experience in adult psoriasis and a lot of comparative safety studies of these drugs in adult psoriasis, there are very few population-based studies on the safety of these systemic agents for treating pediatric psoriasis.”

In an effort to evaluate the 6-month risk of serious bacterial and opportunistic infections in children with psoriasis treated with systemic immunomodulatory medications, Dr. Schneeweiss and Joseph F. Merola, MD, of the department of dermatology at Brigham and Women’s Hospital, Boston, and Jennifer Huang, MD, of Boston Children’s Hospital drew from longitudinal, patient-level U.S. claims data in the MarketScan database between 2003 and 2017. They limited the analysis to patients younger than age 18; those who had a recorded diagnosis of psoriasis; and those who were treated with biologics, nonbiologic immunomodulatory agents, or phototherapy. The researchers used hospital discharge diagnoses to compute the risk of serious bacterial and opportunistic infections, and propensity score matching to determine relative risks.

A total of 54,355 children with psoriasis were identified in the database. Before propensity score matching, 635 patients initiated biologic therapy, 919 initiated nonbiologic systemic agents, and 2,537 initiated phototherapy. Their mean age was 12-14 years and slightly more than half were female. In nonbiologic initiators, the 6-month risk of serious infections was 4.75 per 1,000 patients, while in biologic initiators it was 5.44 per 1,000 patients, resulting in a propensity score–matched ratio of 0.60. There was no statistically significant increased risk when the use of nonbiologics was compared with the use of phototherapy.

Independent of treatment, the risk of infection among psoriasis patients was 1.1 per 1,000 patients, which was 60% higher than matched pediatric patients without psoriasis (risk ratio, 1.64).

“When treating pediatric patients with psoriasis, clinicians should remain mindful that the presence of psoriasis itself may increase the risk of infection in children and adolescents, independent of treatment, but that biologic immunomodulatory agents do not further increase that risk,” Dr. Schneeweiss said in an interview. “Our findings suggest that, while there may be an increased risk of certain infections based on the presence of psoriasis alone, all appropriate treatment options should be discussed with patients in shared decision making with their physician. Patients should understand the risks, benefits, and alternatives to any treatment option but not necessarily be restricted as such and have access to newer, targeted and highly effective therapy as appropriate to each individual case.”

She added that, based on the National Psoriasis Foundation guidance of treat-to-target strategies, “our pediatric patients should be offered the same level of disease control as all psoriasis patients.”

She acknowledged certain limitations of the analysis, including the inability to stratify by disease severity and to determine specific doses of medication used.

The study was funded by the Brigham and Women’s Hospital departments of dermatology and medicine. Dr. Schneeweiss and Dr. Huang reported having no financial disclosures. Dr. Merola reported that he has served as a consultant and/or investigator for numerous pharmaceutical companies.

dbrunk@mdedge.com

AUSTIN, TEX. – Among children with psoriasis, there appears to be no strong evidence that biologic immunomodulating drugs increase the 6-month risk of serious infections, compared with systemic nonbiologics or phototherapy, according to results from the largest population-based study of its kind to date.

However, children with psoriasis face a 64% increased risk of infection, compared with risk-matched pediatric patients without the disease.

“We know that pediatric psoriasis affects up to 1.3% of children, and we know that is associated with multiple potential comorbidities and that it has a significant impact on quality of life for children affected,” lead study author Maria Schneeweiss, MD, said at the annual meeting of the Society for Pediatric Dermatology. “Increasingly, we see that biologic and nonbiologic systemic agents are used to treat moderate to severe pediatric psoriasis. While we have a lot of experience in adult psoriasis and a lot of comparative safety studies of these drugs in adult psoriasis, there are very few population-based studies on the safety of these systemic agents for treating pediatric psoriasis.”

In an effort to evaluate the 6-month risk of serious bacterial and opportunistic infections in children with psoriasis treated with systemic immunomodulatory medications, Dr. Schneeweiss and Joseph F. Merola, MD, of the department of dermatology at Brigham and Women’s Hospital, Boston, and Jennifer Huang, MD, of Boston Children’s Hospital drew from longitudinal, patient-level U.S. claims data in the MarketScan database between 2003 and 2017. They limited the analysis to patients younger than age 18; those who had a recorded diagnosis of psoriasis; and those who were treated with biologics, nonbiologic immunomodulatory agents, or phototherapy. The researchers used hospital discharge diagnoses to compute the risk of serious bacterial and opportunistic infections, and propensity score matching to determine relative risks.

A total of 54,355 children with psoriasis were identified in the database. Before propensity score matching, 635 patients initiated biologic therapy, 919 initiated nonbiologic systemic agents, and 2,537 initiated phototherapy. Their mean age was 12-14 years and slightly more than half were female. In nonbiologic initiators, the 6-month risk of serious infections was 4.75 per 1,000 patients, while in biologic initiators it was 5.44 per 1,000 patients, resulting in a propensity score–matched ratio of 0.60. There was no statistically significant increased risk when the use of nonbiologics was compared with the use of phototherapy.

Independent of treatment, the risk of infection among psoriasis patients was 1.1 per 1,000 patients, which was 60% higher than matched pediatric patients without psoriasis (risk ratio, 1.64).

“When treating pediatric patients with psoriasis, clinicians should remain mindful that the presence of psoriasis itself may increase the risk of infection in children and adolescents, independent of treatment, but that biologic immunomodulatory agents do not further increase that risk,” Dr. Schneeweiss said in an interview. “Our findings suggest that, while there may be an increased risk of certain infections based on the presence of psoriasis alone, all appropriate treatment options should be discussed with patients in shared decision making with their physician. Patients should understand the risks, benefits, and alternatives to any treatment option but not necessarily be restricted as such and have access to newer, targeted and highly effective therapy as appropriate to each individual case.”

She added that, based on the National Psoriasis Foundation guidance of treat-to-target strategies, “our pediatric patients should be offered the same level of disease control as all psoriasis patients.”

She acknowledged certain limitations of the analysis, including the inability to stratify by disease severity and to determine specific doses of medication used.

The study was funded by the Brigham and Women’s Hospital departments of dermatology and medicine. Dr. Schneeweiss and Dr. Huang reported having no financial disclosures. Dr. Merola reported that he has served as a consultant and/or investigator for numerous pharmaceutical companies.

dbrunk@mdedge.com

The Food and Drug Administration has approved the Humira biosimilar Hadlima (adalimumab-bwwd), making it the fourth adalimumab biosimilar approved in the United States, the agency announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Hadlima is approved for seven of the reference product’s indications, which include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, and ulcerative colitis.

The product will launch in the United States on June 30, 2023. Other FDA-approved adalimumab biosimilars – Amjevita (adalimunab-atto), Cyltezo (adalimumab-adbm), Hyrimoz (adalimumab-adaz) – similarly will not reach the U.S. market until 2023.

Hadlima is developed by Samsung Bioepis and commercialized by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.

*This article was updated on July 24, 2019.

jevans@mdedge.com

The Food and Drug Administration has approved the Humira biosimilar Hadlima (adalimumab-bwwd), making it the fourth adalimumab biosimilar approved in the United States, the agency announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Hadlima is approved for seven of the reference product’s indications, which include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, and ulcerative colitis.

The product will launch in the United States on June 30, 2023. Other FDA-approved adalimumab biosimilars – Amjevita (adalimunab-atto), Cyltezo (adalimumab-adbm), Hyrimoz (adalimumab-adaz) – similarly will not reach the U.S. market until 2023.

Hadlima is developed by Samsung Bioepis and commercialized by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.

*This article was updated on July 24, 2019.

jevans@mdedge.com

The Food and Drug Administration has approved the Humira biosimilar Hadlima (adalimumab-bwwd), making it the fourth adalimumab biosimilar approved in the United States, the agency announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Hadlima is approved for seven of the reference product’s indications, which include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, and ulcerative colitis.

The product will launch in the United States on June 30, 2023. Other FDA-approved adalimumab biosimilars – Amjevita (adalimunab-atto), Cyltezo (adalimumab-adbm), Hyrimoz (adalimumab-adaz) – similarly will not reach the U.S. market until 2023.

Hadlima is developed by Samsung Bioepis and commercialized by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.

*This article was updated on July 24, 2019.

jevans@mdedge.com

NEWPORT BEACH, CALIF. – Psoriasis often clears in pregnant women, giving them a rare break from the skin disease. But there still are plenty of reasons to pay close attention to psoriasis drugs in any women who is or could become pregnant.

Bruce Jancin/Frontline Medical News

Data from 2011 found 45% of pregnancies in U.S. women aged 15-44 years were unintended (N Engl J Med. 2016 Mar 3;374[9]:843-52), cautioned Jashin J. Wu, MD, of Dermatology Research and Education Foundation, Irvine, Calif.

In a presentation at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar, Dr. Wu offered these tips about pregnancy and psoriasis:

Counsel patients before pregnancy

There’s conflicting data about the risks of psoriasis in pregnancy, Dr. Wu said. One 23-year-old study suggests a link to adverse outcomes such as preterm and low-birth-weight babies. But another more recent study found no sign of increased risk (Int J Dermatol. 1996;35:169-72; J Am Acad Dermatol. 2011;64:71-7).

Counseling can include information about risks such as hospitalization during pregnancy because of undertreatment of psoriasis, he said. Discuss lowering medication doses to the lowest effective dose, he recommended, and talk about alternatives to systemic medications.

Make adjustments to timing as needed

In patients with severe cases, it may be appropriate to recommend that they postpone pregnancy until their psoriasis is under better control. As for treatment of psoriasis, “you may want to consider timing medication to end around the first trimester to get the medication out of them during the greatest risk period for the baby,” Dr. Wu said.

Adjust steroids as necessary

There are no “good” studies about the use of steroids in pregnant women with psoriasis, Dr. Wu said. “We can probably assume they are safe overall. Weaker steroids may have less risk,” and some of the stronger steroids may raise concerns.

Dr. Wu made these recommendations: Limit mild-potency topical corticosteroids to less than 100 g/week, potent topical corticosteroids to less than 50 g/week, and superpotent topical corticosteroids to less than 30 g/week.

Some topical drugs appear to be OK

Vitamin D analogues have not been well-studied in pregnancy, he said, but “we consider topical use to be fairly safe.”

There’s no data on calcineurin inhibitors in pregnancy, he said, but topical use is considered to be safe because there’s limited systemic absorption.

Beware of certain drugs in pregnancyTazarotene is considered to be dangerous in pregnancy, Dr. Wu said, and females of childbearing age who take it should use effective contraception, and have a recent negative pregnancy test (within 2 weeks before treatment begins). “In general, I’d probably not use this,” he said. “We have so many other options.”

Data about pregnancy safety for three topical drugs – coal tar, anthralin, and salicylic acid – is limited or nonexistent, Dr. Wu said, and he recommends against their use in pregnancy.

Phototherapy is OK in pregnancy

Phototherapy is considered safe because UVB doesn’t penetrate the superficial layer of the skin, he said. But phototherapy brings a potential risk of lowered folic acid levels, and he urges folic acid supplementation in women undergoing the treatment who are considering pregnancy or who are in the first trimester.

Avoid certain systemic drugs

Dr. Wu offered these recommendations:

• Methotrexate: Do not take during pregnancy, or 3 months prior to conception.
• Acitretin (Soriatane): Avoid all use in women who may become pregnant.
• Cyclosporine: Be aware of reports of prematurity and low birth weight linked to the drug.
• Apremilast (Otezla): Animal studies have shown a risk in pregnancy. Stop the drug at least 2 days before conception.

Avoid monoclonal antibodies

These drugs “result in therapeutic levels in the fetus, which is not a good thing,” Dr. Wu said. “You obviously don’t want to have monoclonal antibodies in the baby.”

Nix the PUVA

While one study found no link between psoralen plus UVA (PUVA) and birth defects (Arch Dermatol. 1993 Mar;129[3]:320-3), there’s still a theoretical risk, Dr. Wu said. He recommended that the treatment be avoided during pregnancy.

Watch for waxing and waning

Dr. Wu pointed to a small 2005 study that suggested that psoriasis activity declines during pregnancy. The study used different measures, finding that psoriasis improved by 30% (based on at least a 3% change in body surface area) or 55% (based on patient self-reporting). But it flares after pregnancy as reported by 65% of women surveyed; a body surface area analysis found that psoriasis worsened in 41% (Arch Dermatol. 2005 May;141[5]:601-6).

Dr. Wu reports various relationships (research, consultation and speaking) with 15 pharmaceutical companies. SDEF and this news organization are owned by the same parent company.

NEWPORT BEACH, CALIF. – Psoriasis often clears in pregnant women, giving them a rare break from the skin disease. But there still are plenty of reasons to pay close attention to psoriasis drugs in any women who is or could become pregnant.

Bruce Jancin/Frontline Medical News

Data from 2011 found 45% of pregnancies in U.S. women aged 15-44 years were unintended (N Engl J Med. 2016 Mar 3;374[9]:843-52), cautioned Jashin J. Wu, MD, of Dermatology Research and Education Foundation, Irvine, Calif.

In a presentation at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar, Dr. Wu offered these tips about pregnancy and psoriasis:

Counsel patients before pregnancy

There’s conflicting data about the risks of psoriasis in pregnancy, Dr. Wu said. One 23-year-old study suggests a link to adverse outcomes such as preterm and low-birth-weight babies. But another more recent study found no sign of increased risk (Int J Dermatol. 1996;35:169-72; J Am Acad Dermatol. 2011;64:71-7).

Counseling can include information about risks such as hospitalization during pregnancy because of undertreatment of psoriasis, he said. Discuss lowering medication doses to the lowest effective dose, he recommended, and talk about alternatives to systemic medications.

Make adjustments to timing as needed

In patients with severe cases, it may be appropriate to recommend that they postpone pregnancy until their psoriasis is under better control. As for treatment of psoriasis, “you may want to consider timing medication to end around the first trimester to get the medication out of them during the greatest risk period for the baby,” Dr. Wu said.

Adjust steroids as necessary

There are no “good” studies about the use of steroids in pregnant women with psoriasis, Dr. Wu said. “We can probably assume they are safe overall. Weaker steroids may have less risk,” and some of the stronger steroids may raise concerns.

Dr. Wu made these recommendations: Limit mild-potency topical corticosteroids to less than 100 g/week, potent topical corticosteroids to less than 50 g/week, and superpotent topical corticosteroids to less than 30 g/week.

Some topical drugs appear to be OK

Vitamin D analogues have not been well-studied in pregnancy, he said, but “we consider topical use to be fairly safe.”

There’s no data on calcineurin inhibitors in pregnancy, he said, but topical use is considered to be safe because there’s limited systemic absorption.

Beware of certain drugs in pregnancyTazarotene is considered to be dangerous in pregnancy, Dr. Wu said, and females of childbearing age who take it should use effective contraception, and have a recent negative pregnancy test (within 2 weeks before treatment begins). “In general, I’d probably not use this,” he said. “We have so many other options.”

Data about pregnancy safety for three topical drugs – coal tar, anthralin, and salicylic acid – is limited or nonexistent, Dr. Wu said, and he recommends against their use in pregnancy.

Phototherapy is OK in pregnancy

Phototherapy is considered safe because UVB doesn’t penetrate the superficial layer of the skin, he said. But phototherapy brings a potential risk of lowered folic acid levels, and he urges folic acid supplementation in women undergoing the treatment who are considering pregnancy or who are in the first trimester.

Avoid certain systemic drugs

Dr. Wu offered these recommendations:

• Methotrexate: Do not take during pregnancy, or 3 months prior to conception.
• Acitretin (Soriatane): Avoid all use in women who may become pregnant.
• Cyclosporine: Be aware of reports of prematurity and low birth weight linked to the drug.
• Apremilast (Otezla): Animal studies have shown a risk in pregnancy. Stop the drug at least 2 days before conception.

Avoid monoclonal antibodies

These drugs “result in therapeutic levels in the fetus, which is not a good thing,” Dr. Wu said. “You obviously don’t want to have monoclonal antibodies in the baby.”

Nix the PUVA

While one study found no link between psoralen plus UVA (PUVA) and birth defects (Arch Dermatol. 1993 Mar;129[3]:320-3), there’s still a theoretical risk, Dr. Wu said. He recommended that the treatment be avoided during pregnancy.

Watch for waxing and waning

Dr. Wu pointed to a small 2005 study that suggested that psoriasis activity declines during pregnancy. The study used different measures, finding that psoriasis improved by 30% (based on at least a 3% change in body surface area) or 55% (based on patient self-reporting). But it flares after pregnancy as reported by 65% of women surveyed; a body surface area analysis found that psoriasis worsened in 41% (Arch Dermatol. 2005 May;141[5]:601-6).

Dr. Wu reports various relationships (research, consultation and speaking) with 15 pharmaceutical companies. SDEF and this news organization are owned by the same parent company.

NEWPORT BEACH, CALIF. – Psoriasis often clears in pregnant women, giving them a rare break from the skin disease. But there still are plenty of reasons to pay close attention to psoriasis drugs in any women who is or could become pregnant.

Bruce Jancin/Frontline Medical News

Data from 2011 found 45% of pregnancies in U.S. women aged 15-44 years were unintended (N Engl J Med. 2016 Mar 3;374[9]:843-52), cautioned Jashin J. Wu, MD, of Dermatology Research and Education Foundation, Irvine, Calif.

In a presentation at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar, Dr. Wu offered these tips about pregnancy and psoriasis:

Counsel patients before pregnancy

There’s conflicting data about the risks of psoriasis in pregnancy, Dr. Wu said. One 23-year-old study suggests a link to adverse outcomes such as preterm and low-birth-weight babies. But another more recent study found no sign of increased risk (Int J Dermatol. 1996;35:169-72; J Am Acad Dermatol. 2011;64:71-7).

Counseling can include information about risks such as hospitalization during pregnancy because of undertreatment of psoriasis, he said. Discuss lowering medication doses to the lowest effective dose, he recommended, and talk about alternatives to systemic medications.

Make adjustments to timing as needed

In patients with severe cases, it may be appropriate to recommend that they postpone pregnancy until their psoriasis is under better control. As for treatment of psoriasis, “you may want to consider timing medication to end around the first trimester to get the medication out of them during the greatest risk period for the baby,” Dr. Wu said.

Adjust steroids as necessary

There are no “good” studies about the use of steroids in pregnant women with psoriasis, Dr. Wu said. “We can probably assume they are safe overall. Weaker steroids may have less risk,” and some of the stronger steroids may raise concerns.

Dr. Wu made these recommendations: Limit mild-potency topical corticosteroids to less than 100 g/week, potent topical corticosteroids to less than 50 g/week, and superpotent topical corticosteroids to less than 30 g/week.

Some topical drugs appear to be OK

Vitamin D analogues have not been well-studied in pregnancy, he said, but “we consider topical use to be fairly safe.”

There’s no data on calcineurin inhibitors in pregnancy, he said, but topical use is considered to be safe because there’s limited systemic absorption.

Beware of certain drugs in pregnancyTazarotene is considered to be dangerous in pregnancy, Dr. Wu said, and females of childbearing age who take it should use effective contraception, and have a recent negative pregnancy test (within 2 weeks before treatment begins). “In general, I’d probably not use this,” he said. “We have so many other options.”

Data about pregnancy safety for three topical drugs – coal tar, anthralin, and salicylic acid – is limited or nonexistent, Dr. Wu said, and he recommends against their use in pregnancy.

Phototherapy is OK in pregnancy

Phototherapy is considered safe because UVB doesn’t penetrate the superficial layer of the skin, he said. But phototherapy brings a potential risk of lowered folic acid levels, and he urges folic acid supplementation in women undergoing the treatment who are considering pregnancy or who are in the first trimester.

Avoid certain systemic drugs

Dr. Wu offered these recommendations:

• Methotrexate: Do not take during pregnancy, or 3 months prior to conception.
• Acitretin (Soriatane): Avoid all use in women who may become pregnant.
• Cyclosporine: Be aware of reports of prematurity and low birth weight linked to the drug.
• Apremilast (Otezla): Animal studies have shown a risk in pregnancy. Stop the drug at least 2 days before conception.

Avoid monoclonal antibodies

These drugs “result in therapeutic levels in the fetus, which is not a good thing,” Dr. Wu said. “You obviously don’t want to have monoclonal antibodies in the baby.”

Nix the PUVA

While one study found no link between psoralen plus UVA (PUVA) and birth defects (Arch Dermatol. 1993 Mar;129[3]:320-3), there’s still a theoretical risk, Dr. Wu said. He recommended that the treatment be avoided during pregnancy.

Watch for waxing and waning

Dr. Wu pointed to a small 2005 study that suggested that psoriasis activity declines during pregnancy. The study used different measures, finding that psoriasis improved by 30% (based on at least a 3% change in body surface area) or 55% (based on patient self-reporting). But it flares after pregnancy as reported by 65% of women surveyed; a body surface area analysis found that psoriasis worsened in 41% (Arch Dermatol. 2005 May;141[5]:601-6).

Dr. Wu reports various relationships (research, consultation and speaking) with 15 pharmaceutical companies. SDEF and this news organization are owned by the same parent company.

In a phase 3, active comparator controlled trial, treatment with risankizumab led to better skin clearance than treatment with adalimumab in patients with moderate-to-severe plaque psoriasis. Results of the IMMvent trial were published online ahead of print July 4 in the Lancet.

Risankizumab targets the p19 subunit of the cytokine IL-23. Selectivity for p19 has the potential to be safer than some other approaches that target the p40 subunit, because p19 is specific to IL-23, and many immune defense processes can function without IL-23. The p40 subunit is shared with IL-12, and blocking it can therefore lead to off-target effects.

Risankizumab was previously shown to have superior safety and efficacy over ustekinumab, which inhibits a subunit shared by IL-23 and IL-12 (Gordon KB et al. Lancet. 2018;392[10148]:650-61). Adalimumab is a TNF-alpha inhibitor that is frequently used to treat psoriasis, and which became available in biosimilar form in Europe in 2018.

The researchers randomized 605 adult patients from 66 sites in 11 countries to receive either risankizumab or adalimumab. The first phase (Part A) of the trial lasted up to 16 weeks, and tested the general superiority of risankizumab over adalimumab. The second phase (Part B), from week 16 to 44, evaluated the efficacy of risankizumab in participants who experienced an intermediate response, defined as Psoriasis Area and Severity Index (PASI) score of 50-90.

At the start of Part B, subjects initially receiving adalimumab who had at least a 90% improvement in PASI stayed on adalimumab (PASI 90), while those who had less than 50% improvement in PASI were switched to risankizumab. The remaining intermediate responders (PASI 50-90) were re-randomized to continue adalimumab or switch to risankizumab. All subjects initially randomized to risankizumab continued risankizumab during part B.

At the end of Part A, 72% of the risankizumab group achieved PASI 90, compared with 47% in the adalimumab group (p < 0.0001). A total of 84% in the risankizumab group had a static Physician’s Global Assessment (sPGA) score of 0 or 1 at the end of Part A, compared with 60% in the adalimumab group (p < 0.0001).

During Part B, among intermediate adalimumab responders, 66% of those switched to risankizumab achieved PASI 90, compared with 21% of continued on adalimumab (p < 0.0001).

In Part A, 56% of patients taking risankizumab experienced an adverse event, as did 57% of those taking adalimumab. Among adalimumab intermediate responders, 75% of those who switched to risankizumab during Part B had an adverse event, compared with 66% of those who continued adalimumab.

SOURCE: Reich K, et al. Lancet 2019, July 4 .

In a phase 3, active comparator controlled trial, treatment with risankizumab led to better skin clearance than treatment with adalimumab in patients with moderate-to-severe plaque psoriasis. Results of the IMMvent trial were published online ahead of print July 4 in the Lancet.

Risankizumab targets the p19 subunit of the cytokine IL-23. Selectivity for p19 has the potential to be safer than some other approaches that target the p40 subunit, because p19 is specific to IL-23, and many immune defense processes can function without IL-23. The p40 subunit is shared with IL-12, and blocking it can therefore lead to off-target effects.

Risankizumab was previously shown to have superior safety and efficacy over ustekinumab, which inhibits a subunit shared by IL-23 and IL-12 (Gordon KB et al. Lancet. 2018;392[10148]:650-61). Adalimumab is a TNF-alpha inhibitor that is frequently used to treat psoriasis, and which became available in biosimilar form in Europe in 2018.

The researchers randomized 605 adult patients from 66 sites in 11 countries to receive either risankizumab or adalimumab. The first phase (Part A) of the trial lasted up to 16 weeks, and tested the general superiority of risankizumab over adalimumab. The second phase (Part B), from week 16 to 44, evaluated the efficacy of risankizumab in participants who experienced an intermediate response, defined as Psoriasis Area and Severity Index (PASI) score of 50-90.

At the start of Part B, subjects initially receiving adalimumab who had at least a 90% improvement in PASI stayed on adalimumab (PASI 90), while those who had less than 50% improvement in PASI were switched to risankizumab. The remaining intermediate responders (PASI 50-90) were re-randomized to continue adalimumab or switch to risankizumab. All subjects initially randomized to risankizumab continued risankizumab during part B.

At the end of Part A, 72% of the risankizumab group achieved PASI 90, compared with 47% in the adalimumab group (p < 0.0001). A total of 84% in the risankizumab group had a static Physician’s Global Assessment (sPGA) score of 0 or 1 at the end of Part A, compared with 60% in the adalimumab group (p < 0.0001).

During Part B, among intermediate adalimumab responders, 66% of those switched to risankizumab achieved PASI 90, compared with 21% of continued on adalimumab (p < 0.0001).

In Part A, 56% of patients taking risankizumab experienced an adverse event, as did 57% of those taking adalimumab. Among adalimumab intermediate responders, 75% of those who switched to risankizumab during Part B had an adverse event, compared with 66% of those who continued adalimumab.

SOURCE: Reich K, et al. Lancet 2019, July 4 .

In a phase 3, active comparator controlled trial, treatment with risankizumab led to better skin clearance than treatment with adalimumab in patients with moderate-to-severe plaque psoriasis. Results of the IMMvent trial were published online ahead of print July 4 in the Lancet.

Risankizumab targets the p19 subunit of the cytokine IL-23. Selectivity for p19 has the potential to be safer than some other approaches that target the p40 subunit, because p19 is specific to IL-23, and many immune defense processes can function without IL-23. The p40 subunit is shared with IL-12, and blocking it can therefore lead to off-target effects.

Risankizumab was previously shown to have superior safety and efficacy over ustekinumab, which inhibits a subunit shared by IL-23 and IL-12 (Gordon KB et al. Lancet. 2018;392[10148]:650-61). Adalimumab is a TNF-alpha inhibitor that is frequently used to treat psoriasis, and which became available in biosimilar form in Europe in 2018.

The researchers randomized 605 adult patients from 66 sites in 11 countries to receive either risankizumab or adalimumab. The first phase (Part A) of the trial lasted up to 16 weeks, and tested the general superiority of risankizumab over adalimumab. The second phase (Part B), from week 16 to 44, evaluated the efficacy of risankizumab in participants who experienced an intermediate response, defined as Psoriasis Area and Severity Index (PASI) score of 50-90.

At the start of Part B, subjects initially receiving adalimumab who had at least a 90% improvement in PASI stayed on adalimumab (PASI 90), while those who had less than 50% improvement in PASI were switched to risankizumab. The remaining intermediate responders (PASI 50-90) were re-randomized to continue adalimumab or switch to risankizumab. All subjects initially randomized to risankizumab continued risankizumab during part B.

At the end of Part A, 72% of the risankizumab group achieved PASI 90, compared with 47% in the adalimumab group (p < 0.0001). A total of 84% in the risankizumab group had a static Physician’s Global Assessment (sPGA) score of 0 or 1 at the end of Part A, compared with 60% in the adalimumab group (p < 0.0001).

During Part B, among intermediate adalimumab responders, 66% of those switched to risankizumab achieved PASI 90, compared with 21% of continued on adalimumab (p < 0.0001).

In Part A, 56% of patients taking risankizumab experienced an adverse event, as did 57% of those taking adalimumab. Among adalimumab intermediate responders, 75% of those who switched to risankizumab during Part B had an adverse event, compared with 66% of those who continued adalimumab.

SOURCE: Reich K, et al. Lancet 2019, July 4 .

MILAN – A novel topical nonsteroidal treatment for psoriasis showed sufficient efficacy in phase 2b clinical trials to proceed to phase 3 studies, with improvements in severity, pain, and burning in adults with mild to moderate psoriasis.

At the end of 12 weeks of treatment, 29% of patients receiving the medication – which targets nerve pathways – experienced a decrease of at least 2 grades on the 5-point Investigator’s Global Assessment (IGA) scale, compared with 13% of those receiving the topical vehicle only (P = .036). A similar proportion of patients achieved 75% improvement on the Psoriasis Area and Severity Index (PASI-75)compared with those on vehicle alone (27% versus 13%; P = .045).

These findings were seen only with the less concentrated formulation of pegcantratinib, known as SNA-120 in the clinical trial program, said Paul F. Lizzul, MD, PhD, presenting the findings during a late-breaking abstract session at the World Congress of Dermatology.

Pruritus severity also dropped by about 60%, but the decrease did not differ significantly from the change seen with vehicle alone, said Dr. Lizzul, chief medical officer for Sienna Biopharmaceuticals, Westlake Village, Calif., which funded the study. He and his coinvestigators found this “interesting, surprising, and different from what we had seen previously,” he said. “We think a few things happened here,” including intensive querying on itch by means of daily diaries, a different approach than had been taken in the investigator’s earlier SNA-120 trials. “We think in this way we probably biased patients’ expectations, altering reporting on this subjective measure,” he added.

“There’s been really a lack of innovation in the topical world in developing nonsteroidal therapies for the majority of patients who are treated with topicals, said Dr. Lizzul. Keratinocytes within psoriatic plaques are known to have elevated levels of nerve growth factor (NGF), he explained. Together with tropomyosin receptor kinase A (TrkA), NGF is implicated in the pathogenesis of psoriasis; it stimulates keratinocyte hyperproliferation, is a factor in neurogenic inflammation, and contributes to pruritus. Upregulation of TrkA expression is seen in nerve fibers within pruritic psoriasis plaques as well, said Dr. Lizzul, senior author of the study. (The first author was Kristina Callis Duffin, MD, cochair of the dermatology department at the University of Utah, Salt Lake City.)

In fact, the pruritus that plagues many psoriasis patients, said Dr. Lizzul, may “serve as a clinical biomarker for elevated NGF/TrkA expression.” And certain clinical phenomena observed in psoriasis, such as the Koebner phenomenon and plaque resolution along the path of damaged nerves, provide other clues. “Clearly, astute clinicians going back many, many years have recognized the very important role that nerves and neuropeptides play in psoriasis,” he added.

SNA-120 targets NGF TrKA activity, and “achieves high local drug concentration in the skin, with low systemic availability,” he said.

The randomized, double-blind, vehicle-controlled study enrolled 208 adults with mild to moderate psoriasis (scores of 2 or 3 on the IGA), with pruritus of at least moderate intensity (5 or higher on a 10-point itch numeric rating scale, or I-NRS). The mean age of the patients was 50 years, and about half were male. Most (84%-90% across study arms) were white. At baseline, the mean I-NRS was 7.3-7.4, and the mean PASI score at baseline ranged from 5.9 to 6.5.


Patients were randomized to receive SNA-120 twice daily at either 0.05% (70 patients) or 0.5% (69 patients) in an ointment formulation, or vehicle alone twice daily (69 patients). Efficacy was tracked by measuring decrease in IGA by one or two grades, the number of patients achieving PASI-50 and PASI-75, reduction in itch, and a composite of a decrease of at least 2 grades on the IGA and having clear or almost clear skin.

The investigators also tracked reduction in burning and pain as measured on a 10-point numeric rating scale. Though itch scores didn’t differ significantly from reductions seen with the topical vehicle alone, pain and burning were both reduced significantly compared with vehicle by week 12 of the study (P = .033 for pain; P = .043 for burning).

All improvements were seen only with the lower dose, not the 0.5% dose of SNA-120, noted Dr. Lizzul, adding: “This is not necessarily surprising in the world of kinase inhibitors, where you can see these J-shaped or inverse dose-response curves.”

In addition to recording adverse events, the researchers assessed safety by obtaining laboratory values and electrocardiograms. Plasma SNA-120 levels at study weeks 2, 4, and 8 were obtained for pharmacokinetic analysis. Systemic uptake was virtually nil, and the safety profile overall was good, said Dr. Lizzul.

Next steps are phase 3 clinical trials that will evaluate global improvement as well as pain, burning, and itch in psoriasis, he noted.

Dr. Lizzul is an employee of Sienna Biopharmaceuticals, which is developing SNA-120.

koakes@mdedge.com

MILAN – A novel topical nonsteroidal treatment for psoriasis showed sufficient efficacy in phase 2b clinical trials to proceed to phase 3 studies, with improvements in severity, pain, and burning in adults with mild to moderate psoriasis.

At the end of 12 weeks of treatment, 29% of patients receiving the medication – which targets nerve pathways – experienced a decrease of at least 2 grades on the 5-point Investigator’s Global Assessment (IGA) scale, compared with 13% of those receiving the topical vehicle only (P = .036). A similar proportion of patients achieved 75% improvement on the Psoriasis Area and Severity Index (PASI-75)compared with those on vehicle alone (27% versus 13%; P = .045).

These findings were seen only with the less concentrated formulation of pegcantratinib, known as SNA-120 in the clinical trial program, said Paul F. Lizzul, MD, PhD, presenting the findings during a late-breaking abstract session at the World Congress of Dermatology.

Pruritus severity also dropped by about 60%, but the decrease did not differ significantly from the change seen with vehicle alone, said Dr. Lizzul, chief medical officer for Sienna Biopharmaceuticals, Westlake Village, Calif., which funded the study. He and his coinvestigators found this “interesting, surprising, and different from what we had seen previously,” he said. “We think a few things happened here,” including intensive querying on itch by means of daily diaries, a different approach than had been taken in the investigator’s earlier SNA-120 trials. “We think in this way we probably biased patients’ expectations, altering reporting on this subjective measure,” he added.

“There’s been really a lack of innovation in the topical world in developing nonsteroidal therapies for the majority of patients who are treated with topicals, said Dr. Lizzul. Keratinocytes within psoriatic plaques are known to have elevated levels of nerve growth factor (NGF), he explained. Together with tropomyosin receptor kinase A (TrkA), NGF is implicated in the pathogenesis of psoriasis; it stimulates keratinocyte hyperproliferation, is a factor in neurogenic inflammation, and contributes to pruritus. Upregulation of TrkA expression is seen in nerve fibers within pruritic psoriasis plaques as well, said Dr. Lizzul, senior author of the study. (The first author was Kristina Callis Duffin, MD, cochair of the dermatology department at the University of Utah, Salt Lake City.)

In fact, the pruritus that plagues many psoriasis patients, said Dr. Lizzul, may “serve as a clinical biomarker for elevated NGF/TrkA expression.” And certain clinical phenomena observed in psoriasis, such as the Koebner phenomenon and plaque resolution along the path of damaged nerves, provide other clues. “Clearly, astute clinicians going back many, many years have recognized the very important role that nerves and neuropeptides play in psoriasis,” he added.

SNA-120 targets NGF TrKA activity, and “achieves high local drug concentration in the skin, with low systemic availability,” he said.

The randomized, double-blind, vehicle-controlled study enrolled 208 adults with mild to moderate psoriasis (scores of 2 or 3 on the IGA), with pruritus of at least moderate intensity (5 or higher on a 10-point itch numeric rating scale, or I-NRS). The mean age of the patients was 50 years, and about half were male. Most (84%-90% across study arms) were white. At baseline, the mean I-NRS was 7.3-7.4, and the mean PASI score at baseline ranged from 5.9 to 6.5.


Patients were randomized to receive SNA-120 twice daily at either 0.05% (70 patients) or 0.5% (69 patients) in an ointment formulation, or vehicle alone twice daily (69 patients). Efficacy was tracked by measuring decrease in IGA by one or two grades, the number of patients achieving PASI-50 and PASI-75, reduction in itch, and a composite of a decrease of at least 2 grades on the IGA and having clear or almost clear skin.

The investigators also tracked reduction in burning and pain as measured on a 10-point numeric rating scale. Though itch scores didn’t differ significantly from reductions seen with the topical vehicle alone, pain and burning were both reduced significantly compared with vehicle by week 12 of the study (P = .033 for pain; P = .043 for burning).

All improvements were seen only with the lower dose, not the 0.5% dose of SNA-120, noted Dr. Lizzul, adding: “This is not necessarily surprising in the world of kinase inhibitors, where you can see these J-shaped or inverse dose-response curves.”

In addition to recording adverse events, the researchers assessed safety by obtaining laboratory values and electrocardiograms. Plasma SNA-120 levels at study weeks 2, 4, and 8 were obtained for pharmacokinetic analysis. Systemic uptake was virtually nil, and the safety profile overall was good, said Dr. Lizzul.

Next steps are phase 3 clinical trials that will evaluate global improvement as well as pain, burning, and itch in psoriasis, he noted.

Dr. Lizzul is an employee of Sienna Biopharmaceuticals, which is developing SNA-120.

koakes@mdedge.com

MILAN – A novel topical nonsteroidal treatment for psoriasis showed sufficient efficacy in phase 2b clinical trials to proceed to phase 3 studies, with improvements in severity, pain, and burning in adults with mild to moderate psoriasis.

At the end of 12 weeks of treatment, 29% of patients receiving the medication – which targets nerve pathways – experienced a decrease of at least 2 grades on the 5-point Investigator’s Global Assessment (IGA) scale, compared with 13% of those receiving the topical vehicle only (P = .036). A similar proportion of patients achieved 75% improvement on the Psoriasis Area and Severity Index (PASI-75)compared with those on vehicle alone (27% versus 13%; P = .045).

These findings were seen only with the less concentrated formulation of pegcantratinib, known as SNA-120 in the clinical trial program, said Paul F. Lizzul, MD, PhD, presenting the findings during a late-breaking abstract session at the World Congress of Dermatology.

Pruritus severity also dropped by about 60%, but the decrease did not differ significantly from the change seen with vehicle alone, said Dr. Lizzul, chief medical officer for Sienna Biopharmaceuticals, Westlake Village, Calif., which funded the study. He and his coinvestigators found this “interesting, surprising, and different from what we had seen previously,” he said. “We think a few things happened here,” including intensive querying on itch by means of daily diaries, a different approach than had been taken in the investigator’s earlier SNA-120 trials. “We think in this way we probably biased patients’ expectations, altering reporting on this subjective measure,” he added.

“There’s been really a lack of innovation in the topical world in developing nonsteroidal therapies for the majority of patients who are treated with topicals, said Dr. Lizzul. Keratinocytes within psoriatic plaques are known to have elevated levels of nerve growth factor (NGF), he explained. Together with tropomyosin receptor kinase A (TrkA), NGF is implicated in the pathogenesis of psoriasis; it stimulates keratinocyte hyperproliferation, is a factor in neurogenic inflammation, and contributes to pruritus. Upregulation of TrkA expression is seen in nerve fibers within pruritic psoriasis plaques as well, said Dr. Lizzul, senior author of the study. (The first author was Kristina Callis Duffin, MD, cochair of the dermatology department at the University of Utah, Salt Lake City.)

In fact, the pruritus that plagues many psoriasis patients, said Dr. Lizzul, may “serve as a clinical biomarker for elevated NGF/TrkA expression.” And certain clinical phenomena observed in psoriasis, such as the Koebner phenomenon and plaque resolution along the path of damaged nerves, provide other clues. “Clearly, astute clinicians going back many, many years have recognized the very important role that nerves and neuropeptides play in psoriasis,” he added.

SNA-120 targets NGF TrKA activity, and “achieves high local drug concentration in the skin, with low systemic availability,” he said.

The randomized, double-blind, vehicle-controlled study enrolled 208 adults with mild to moderate psoriasis (scores of 2 or 3 on the IGA), with pruritus of at least moderate intensity (5 or higher on a 10-point itch numeric rating scale, or I-NRS). The mean age of the patients was 50 years, and about half were male. Most (84%-90% across study arms) were white. At baseline, the mean I-NRS was 7.3-7.4, and the mean PASI score at baseline ranged from 5.9 to 6.5.


Patients were randomized to receive SNA-120 twice daily at either 0.05% (70 patients) or 0.5% (69 patients) in an ointment formulation, or vehicle alone twice daily (69 patients). Efficacy was tracked by measuring decrease in IGA by one or two grades, the number of patients achieving PASI-50 and PASI-75, reduction in itch, and a composite of a decrease of at least 2 grades on the IGA and having clear or almost clear skin.

The investigators also tracked reduction in burning and pain as measured on a 10-point numeric rating scale. Though itch scores didn’t differ significantly from reductions seen with the topical vehicle alone, pain and burning were both reduced significantly compared with vehicle by week 12 of the study (P = .033 for pain; P = .043 for burning).

All improvements were seen only with the lower dose, not the 0.5% dose of SNA-120, noted Dr. Lizzul, adding: “This is not necessarily surprising in the world of kinase inhibitors, where you can see these J-shaped or inverse dose-response curves.”

In addition to recording adverse events, the researchers assessed safety by obtaining laboratory values and electrocardiograms. Plasma SNA-120 levels at study weeks 2, 4, and 8 were obtained for pharmacokinetic analysis. Systemic uptake was virtually nil, and the safety profile overall was good, said Dr. Lizzul.

Next steps are phase 3 clinical trials that will evaluate global improvement as well as pain, burning, and itch in psoriasis, he noted.

Dr. Lizzul is an employee of Sienna Biopharmaceuticals, which is developing SNA-120.

koakes@mdedge.com

MILAN – Health-related quality of life improved for patients with moderate to severe genital psoriasis while they received ixekizumab, according to data presented at the World Congress of Dermatology.

After 12 weeks of ixekizumab administration, nearly half of patients who received ixekizumab in the randomized, double-blind, placebo-controlled trial achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, compared with fewer than 5% of those receiving placebo. At the end of one year, 46.7% of the original ixekizumab group and 50.8% of those who transitioned to ixekizumab from placebo via an open-label extension arm achieved a DLQI of 0 or 1. A DLQI score of 0 or 1 on a 30-point scale indicated that psoriasis had no effect on health-related quality of life.

Among patients with plaque psoriasis, genital involvement is common – present in over 60% at some point during the disease course, Lyn Guenther, MD, of Guenther Dermatology Research Centre, London, Ont., and her colleagues wrote in the poster accompanying the presentation. Sexual health and overall quality of life can be negatively affected by genital psoriasis, they added.

In the study, adult patients were included if they had chronic plaque psoriasis present in genital and nongenital areas. For overall psoriasis and genital involvement, the Static Physician’s Global Assessment (sPGA) was 3 or greater, and total body surface area involvement was at least 1%. Also, patients had to have failed or been intolerant to at least one topical therapy for genital psoriasis.

Patients were excluded if they had genital pustules or vesicles, significant uncontrolled medical or psychiatric comorbidities, recent infection, or prior interleukin-17 antagonist treatment.

In all, patients received ixekizumab 160 mg (75 patients) or placebo (74) subcutaneously every 2 weeks during the initial 12-week study period. For the open-label extension arm, 74 patients in the active arm and 65 patients in the placebo arm went on to receive 80 mg of ixekizumab every 4 weeks, with a step-up option to every other week dosing depending on clinical response.

Patients were given the Short Form Health Survey (SF-36) at baseline and at week 12 and week 52; investigators recorded the mean change for baseline for both the physical and mental component.

Participants also completed the DLQI, which was administered nine times over the 52-week study period.

From baseline, SF-36 scores climbed in both the physical and mental domains for those on ixekizumab, wrote Dr. Guenther and her coinvestigators, with “improvements in all SF-36 domains” for those on ixekizumab at 12 weeks, which continued through week 52. For patients who transitioned to ixekizumab from placebo, “improvements in all SF-36 domains were achieved at week 52,” they wrote.

The mean change from baseline on the SF-36 for the ixekizumab population was 3.5 on the physical domain and 4.8 on the mental component. For the placebo-ixekizumab group, scores improved by a mean 4.5 on the physical domain and 4.9 on the mental domain. Those who stayed on ixekizumab saw some decline in SF-36 scores, with a physical component improvement of 2.5 and mental component improvement of 3.6 at 52 weeks.

Ixekizumab (Taltz), a monoclonal antibody targeting interleukin-17A, is approved for moderate to severe plaque psoriasis, and active psoriatic arthritis..

“Ixekizumab provided clinically meaningful and persistent improvements in HRQoL in patients with moderate to severe genital psoriasis,” wrote Dr. Guenther and her colleagues.

Dr. Guenther and two coauthors reported receiving remuneration from several pharmaceutical companies, including Eli Lilly, which funded the study. Four coauthors are employees and shareholders of Eli Lilly.

koakes@mdedge.com

MILAN – Health-related quality of life improved for patients with moderate to severe genital psoriasis while they received ixekizumab, according to data presented at the World Congress of Dermatology.

After 12 weeks of ixekizumab administration, nearly half of patients who received ixekizumab in the randomized, double-blind, placebo-controlled trial achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, compared with fewer than 5% of those receiving placebo. At the end of one year, 46.7% of the original ixekizumab group and 50.8% of those who transitioned to ixekizumab from placebo via an open-label extension arm achieved a DLQI of 0 or 1. A DLQI score of 0 or 1 on a 30-point scale indicated that psoriasis had no effect on health-related quality of life.

Among patients with plaque psoriasis, genital involvement is common – present in over 60% at some point during the disease course, Lyn Guenther, MD, of Guenther Dermatology Research Centre, London, Ont., and her colleagues wrote in the poster accompanying the presentation. Sexual health and overall quality of life can be negatively affected by genital psoriasis, they added.

In the study, adult patients were included if they had chronic plaque psoriasis present in genital and nongenital areas. For overall psoriasis and genital involvement, the Static Physician’s Global Assessment (sPGA) was 3 or greater, and total body surface area involvement was at least 1%. Also, patients had to have failed or been intolerant to at least one topical therapy for genital psoriasis.

Patients were excluded if they had genital pustules or vesicles, significant uncontrolled medical or psychiatric comorbidities, recent infection, or prior interleukin-17 antagonist treatment.

In all, patients received ixekizumab 160 mg (75 patients) or placebo (74) subcutaneously every 2 weeks during the initial 12-week study period. For the open-label extension arm, 74 patients in the active arm and 65 patients in the placebo arm went on to receive 80 mg of ixekizumab every 4 weeks, with a step-up option to every other week dosing depending on clinical response.

Patients were given the Short Form Health Survey (SF-36) at baseline and at week 12 and week 52; investigators recorded the mean change for baseline for both the physical and mental component.

Participants also completed the DLQI, which was administered nine times over the 52-week study period.

From baseline, SF-36 scores climbed in both the physical and mental domains for those on ixekizumab, wrote Dr. Guenther and her coinvestigators, with “improvements in all SF-36 domains” for those on ixekizumab at 12 weeks, which continued through week 52. For patients who transitioned to ixekizumab from placebo, “improvements in all SF-36 domains were achieved at week 52,” they wrote.

The mean change from baseline on the SF-36 for the ixekizumab population was 3.5 on the physical domain and 4.8 on the mental component. For the placebo-ixekizumab group, scores improved by a mean 4.5 on the physical domain and 4.9 on the mental domain. Those who stayed on ixekizumab saw some decline in SF-36 scores, with a physical component improvement of 2.5 and mental component improvement of 3.6 at 52 weeks.

Ixekizumab (Taltz), a monoclonal antibody targeting interleukin-17A, is approved for moderate to severe plaque psoriasis, and active psoriatic arthritis..

“Ixekizumab provided clinically meaningful and persistent improvements in HRQoL in patients with moderate to severe genital psoriasis,” wrote Dr. Guenther and her colleagues.

Dr. Guenther and two coauthors reported receiving remuneration from several pharmaceutical companies, including Eli Lilly, which funded the study. Four coauthors are employees and shareholders of Eli Lilly.

koakes@mdedge.com

MILAN – Health-related quality of life improved for patients with moderate to severe genital psoriasis while they received ixekizumab, according to data presented at the World Congress of Dermatology.

After 12 weeks of ixekizumab administration, nearly half of patients who received ixekizumab in the randomized, double-blind, placebo-controlled trial achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, compared with fewer than 5% of those receiving placebo. At the end of one year, 46.7% of the original ixekizumab group and 50.8% of those who transitioned to ixekizumab from placebo via an open-label extension arm achieved a DLQI of 0 or 1. A DLQI score of 0 or 1 on a 30-point scale indicated that psoriasis had no effect on health-related quality of life.

Among patients with plaque psoriasis, genital involvement is common – present in over 60% at some point during the disease course, Lyn Guenther, MD, of Guenther Dermatology Research Centre, London, Ont., and her colleagues wrote in the poster accompanying the presentation. Sexual health and overall quality of life can be negatively affected by genital psoriasis, they added.

In the study, adult patients were included if they had chronic plaque psoriasis present in genital and nongenital areas. For overall psoriasis and genital involvement, the Static Physician’s Global Assessment (sPGA) was 3 or greater, and total body surface area involvement was at least 1%. Also, patients had to have failed or been intolerant to at least one topical therapy for genital psoriasis.

Patients were excluded if they had genital pustules or vesicles, significant uncontrolled medical or psychiatric comorbidities, recent infection, or prior interleukin-17 antagonist treatment.

In all, patients received ixekizumab 160 mg (75 patients) or placebo (74) subcutaneously every 2 weeks during the initial 12-week study period. For the open-label extension arm, 74 patients in the active arm and 65 patients in the placebo arm went on to receive 80 mg of ixekizumab every 4 weeks, with a step-up option to every other week dosing depending on clinical response.

Patients were given the Short Form Health Survey (SF-36) at baseline and at week 12 and week 52; investigators recorded the mean change for baseline for both the physical and mental component.

Participants also completed the DLQI, which was administered nine times over the 52-week study period.

From baseline, SF-36 scores climbed in both the physical and mental domains for those on ixekizumab, wrote Dr. Guenther and her coinvestigators, with “improvements in all SF-36 domains” for those on ixekizumab at 12 weeks, which continued through week 52. For patients who transitioned to ixekizumab from placebo, “improvements in all SF-36 domains were achieved at week 52,” they wrote.

The mean change from baseline on the SF-36 for the ixekizumab population was 3.5 on the physical domain and 4.8 on the mental component. For the placebo-ixekizumab group, scores improved by a mean 4.5 on the physical domain and 4.9 on the mental domain. Those who stayed on ixekizumab saw some decline in SF-36 scores, with a physical component improvement of 2.5 and mental component improvement of 3.6 at 52 weeks.

Ixekizumab (Taltz), a monoclonal antibody targeting interleukin-17A, is approved for moderate to severe plaque psoriasis, and active psoriatic arthritis..

“Ixekizumab provided clinically meaningful and persistent improvements in HRQoL in patients with moderate to severe genital psoriasis,” wrote Dr. Guenther and her colleagues.

Dr. Guenther and two coauthors reported receiving remuneration from several pharmaceutical companies, including Eli Lilly, which funded the study. Four coauthors are employees and shareholders of Eli Lilly.

koakes@mdedge.com